BRILLIANT EverGlow Flow

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. June 21, 2019 Coltene/Whaledent AG Wolfgang Dorner Regulatory Affairs Specialist Feldwiesenstrasse 20 Altstatten, 9450 SWITZERLAND Re: K190597 Trade/Device Name: BRILLIANT EverGlow Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: Class II Product Code: EBF Dated: April 1, 2019 Received: April 4, 2019 Dear Wolfgang Dorner: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Srinivas Nandkumar, PhD Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190597 Device Name BRILLIANT EverGlow Flow ### Indications for Use (Describe) BRILLIANT EverGlow Flow Universal and Translucent shades are suitable for: - · Direct class V fillings (cervical caries, root erosion, wedge-shaped defects) - · Fillings in the anterior tooth region (Class III and IV) - · Small fillings of all cavity classes (not occlusion-bearing) - · Blocking out of undercuts - · Adhesive luting of indirect composite and ceramic restorations in as far as accuracy of fit and light permeability are given - · Repairs of direct and indirect composite restorations - · Preventive resin restorations - · Cavity lining BRILLIANT EverGlow Flow opaque shade is also suitable for: - · Aesthetic corrections (e.g. deviations in chroma) - · Masking of dark areas Type of Use (Select one or both, as applicable) | <span> <span style="font-size: 10px;"><b> </b></span> <span style="text-decoration: overline;"><b> </b></span> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span> <span style="font-size: 10px;"><b> </b></span> <span style="text-decoration: overline;"><b> </b></span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------| |---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------| ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### # COL ENE # K190597 # Section 5 - 510(k) Summary # 1. Submitter | Company Name: | Coltène/Whaledent AG | |-----------------|-------------------------------| | Street and Nr.: | Feldwiesenstrasse 20 | | City: | Altstätten | | Post Code: | 9450 | | State/Canton: | Sankt Gallen | | Country: | Switzerland | | Main Contact: | Wolfgang Dörner | | Title: | Regulatory Affairs Specialist | | Phone: | + 41 71 757 5422 | | Email: | wolfgang.doerner@coltene.com | # 2. Date Prepared 1. March 2019 # 3. Device Identification | Trade Name: | BRILLIANT EverGlow Flow® | |-----------------------|------------------------------------------------| | Common Name: | Flowable radiopaque submicron hybrid composite | | Classification Name: | Tooth shade resin material | | Regulation Number: | 872.3690 | | Product Code: | EBF | | Class: | II | | Classification Panel: | Dental | {4}------------------------------------------------ Coltène/Whaledent AG Traditional 510(k) Premarket Submission BRILLIANT EverGlow Flow® ### 4. Legally Marketed Predicate Device(s) The predicate device for BRILLIANT EverGlow Flow is BRILLIANT EverGlow from Coltène/Whaledent. BRILLIANT EverGlow was cleared under the 510(k) number K152927 on 28. April 2019 (Exhibit 5-1). ### 5. Indication for Use BRILLIANT EverGlow Flow Universal and Translucent shades are suitable for: - Direct class V fillings (cervical caries, root erosion, wedge-shaped defects) ● - Fillings in the anterior tooth region (Class III and IV) . - . Small fillings of all cavity classes (not occlusion-bearing) - Blocking out of undercuts . - . Adhesive luting of indirect composite and ceramic restorations in as far as accuracy of fit and light permeability are given - Repairs of direct and indirect composite restorations - Preventive resin restorations . - . Cavity lining BRILLIANT EverGlow Flow opaque shade is also suitable for: - . Aesthetic corrections (e.g. deviations in chroma) - . Masking of dark areas ### 6. Device Overview BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid composite and available in several shades that allows for high aesthetic restorations with a clear spectrum of shades. It is applied in the increment technique and available in 7 universal, 2 translucent and 3 opaque shades. BRILLIANT EverGlow Flow is chemically characterized by its composition, which can be categorized in three groups based on their chemical and functional similarity: resin components (matrix monomers based on methacrylates), fillers, and additives. The largest part of BRILLIANT EverGlow Flow's composition is represented by fillers (>58% w/w), followed by resin components (<40% w/w), and {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "COLTENE" in bold, black letters. To the left of the word is a blue graphic consisting of six squares arranged in two rows of three. The squares in the bottom row are lighter in color than the squares in the top row. additives (<2% w/w). BRILLIANT EverGlow Flow is, after curing, a crosslinked methacrylate-based composite material with a three-dimensional polymer network, containing embedded filler particles and incorporated additives. A detailed description of the chemical composition can be found in Table 3. BRILLIANT EverGlow Flow has long term contact (>30 days) with tissue/bone/dentin. BRILLIANT EverGlow Flow is the supplemental flowable, radiopaque submicron hybrid material version of the universal composite BRILLIANT EverGlow. BRILLIANT EverGlow Flow is, due to its lower viscosity, considered an enhancement of BRILLIANT EverGlow for applications with non-easily accessible areas in the oral cavity (e.g. blocking out of undercuts) and/or extended fissure-sealing. BRILLIANT EverGlow Flow combines a low viscous consistency with high stability and thixotropy, allowing a controlled and comfortable application. BRILLIANT EverGlow Flow is available in different shades and gradations of translucency. BRILLIANT EverGlow Flow is delivered with two application needle sizes (standard size [Ø 0.8mm] and fine size [Ø 0.4mm]). The fine size needle is to improve the accessory range and to allow an application with higher precision. Image /page/5/Picture/5 description: The image shows two syringes of dental composite material and three applicator tips. The syringes are labeled "BRILLIANT EverGlow Flow", with one syringe having a transparent material and the other having a pinkish material. The syringes have black plungers and caps, and the applicator tips are also black with thin, curved metal tips. Figure 1: BRILLIANT EverGlow Flow® is available in syringes (à 2 g) with two application needle sizes (Ø 0.8mm and Ø 0.4mm). {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "COLTENE" in bold, black letters. To the left of the word is a blue graphic consisting of six squares arranged in two rows of three. The squares in the top row are a darker shade of blue than the squares in the bottom row. ### 7. Substantial Equivalence Discussion A comparison of the new device BRILLIANT EverGlow Flow to the predicate device BRILLIANT EverGlow device with respect to its physical state, structure, materials, mechanical properties, indications for use, packaging, biocompatibility and performance testing, is shown in Table 1 and Table 2. | Attributes | New Device | Predicate Device | |---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------| | Device Name | BRILLIANT EverGlow<br>Flow® | BRILLIANT EverGlow®. | | Manufacturer | Coltène/Whaledent AG,<br>Switzerland | Coltène/Whaledent AG,<br>Switzerland | | 510(k) # | | K152927 | | Product Code | EBF | EBF | | Regulation number<br>(21 CFR): | 872.3690 | 872.3690 | | Class | II | II | | Review Panel | Dental | Dental | | Physical State | Viscous paste | Viscous paste | | Structure | Polymer resin composite | Polymer resin composite | | Sizes | Prefilled syringes à 2 g | Prefilled syringes à 3 g and tips<br>à 0.2 g | | Main composition of<br>material | Methacrylates | Methacrylates | | | Dental glass | Dental glass | | | Amorphous silica | Amorphous silica | | | Zinc oxide | Zinc oxide | | Technical Data | Range of dimensions of<br>inorganic | Range of dimensions of<br>inorganic | | | filler particles: 0.02-1.5 µm | filler particles: 0.02-1.5 µm | | | Inorganic filler content by<br>volume: 37 % | Inorganic filler content by<br>volume: 56 % | | | Inorganic filler content by<br>weight: 60 % | Inorganic filler content by<br>weight: 74 % | | Indications for Use | BRILLIANT EverGlow Flow<br>universal and translucent | BRILLIANT EverGlow<br>universal shades Bleach (BL), | | Attributes | New Device | Predicate Device | | | shades are suitable for: | A1/B1, A2/B2, A3/D3,<br>A3,5/B3, C2/C3 and A4/C4 | | | | are indicated for: | | | - Direct class V fillings<br>(cervical caries, root<br>erosion, wedge-shaped<br>defects) | - Direct filling of class I, II, III,<br>IV and V cavities | | | - Fillings in the anterior tooth<br>region (Class III and IV) | - Luting and repairing of<br>ceramic and composite<br>restorations (e.g.<br>COMPONEERR)<br>BRILLIANT EverGlow<br>translucent shades | | | - Small fillings of all cavity<br>classes (not occlusion-bearing) | Translucent (Trans) and<br>Bleach Translucent (BL<br>Trans) are<br>indicated for: | | | - Blocking out of undercuts | - Shape and color corrections<br>to enhance the individual<br>esthetics | | | - Adhesive luting of indirect<br>composite and ceramic<br>restorations in as far as<br>accuracy of fit and light<br>permeability are given | - Reconstruction of incisal<br>edges | | | - Repairs of direct and indirect<br>composite restorations | - Luting and repairing of<br>ceramic and composite<br>restorations (e.g.<br>COMPONEERR)<br>BRILLIANT | | | - Preventive resin restorations | | | | - Cavity lining | | | | BRILLIANT EverGlow Flow<br>opaque shade is also suitable<br>for: | | | | - Aesthetic corrections (e.g.<br>deviations in chroma) | EverGlow opaque shades<br>Opaque Bleach (OBL),<br>Opaque A1 (OA1) and Opaque<br>A3<br>(OA3) are indicated for: | | | - Masking of dark areas | - Aesthetic corrections (e.g.<br>chroma deviations) | | | | - Masking of dark areas | | | | - Forming of a dentin core | | Packaging | Prefilled syringes | Prefilled syringes, tips | | Usage | Single Patient, multiple use | Single Patient, multiple use | | Attributes | New Device | Predicate Device | | | Application by increment<br>technique | Application by increment<br>technique | | Sterility | non-sterile | non-sterile | | Biocompatibility | Conforms with ISO 10993-<br>1:2018 | Conforms with ISO 10993-<br>1:2018 | | Performance | Conforms with ISO 4049:2009 | Conforms with ISO 4049:2009 | ### Table 1: Comparison of overall device characteristics {7}------------------------------------------------ # % COLTENE {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for COLTENE. The logo consists of a blue graphic on the left and the word "COLTENE" in black, bold letters on the right. The graphic is made up of six blue squares arranged in two rows of three, with the squares in the bottom row being slightly lighter in color than the squares in the top row. Table 2: Comparison of main physical and mechanical properties of BRILLIANT EverGlow Flow® with BRILLIANT EverGlow | Criteria | Subject Device:<br>BRILLIANT<br>EverGlow Flow | Predicate Device<br>BRILLIANT<br>EverGlow Flow | Unit | |------------------------------------------------------------------------|-----------------------------------------------|------------------------------------------------|----------| | Flexural strength | 96 | 117 | MPa | | Compressive strength | 415 | 390 | MPa | | Exposure time and Intensity for curing (for<br>photo-initiated resins) | 20s with 800<br>10s with 1600 | 20s with 800<br>10s with 1600 | mW/cm² | | Inorganic filler content | 37 | 74 | Vol-% | | Radio-opacity | 2.2 | 2.0 | mm of Al | | Water sorption | 23 | 15 | μg/mm³ | | Water Solubility | 2.0 | 0.7 | μg/mm³ | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for COLTENE. The logo consists of a blue graphic on the left and the word "COLTENE" in black, bold letters on the right. The graphic is made up of six blue squares arranged in two rows of three, with the squares in the bottom row being slightly lighter in color than the squares in the top row. # Table 3: Chemical Composition of BRILLIANT EverGlow Flow and the predicate device BRILLIANT EverGlow | Subject Device:<br>BRILLIANT EverGlow Flow | Predicate Device:<br>BRILLIANT EverGlow | |--------------------------------------------|-----------------------------------------| | Methacrylates | Methacrylates | | Dental glass | Dental glass | | Amorphous silica | Amorphous silica | | Zinc oxide | Zinc oxide | | Colorants and Additives | Colorants and Additives | | Range of dimensions of inorganic | Range of dimensions of inorganic | | filler particles: 0.02-1.5 µm | filler particles: 0.02-1.5 µm | | Inorganic filler content | Inorganic filler content | | by volume: 37 % | by volume: 56 % | | Inorganic filler content | Inorganic filler content | | by weight: 60 % | by weight: 74 % | | Complies with ISO 4049 | Complies with ISO 4049 | ### 8. Non-Clinical Performance Data As part of demonstrating substantial equivalence of BRILLIANT EverGlow Flow to the predicate device, Coltène/Whaledent extensive testing of the finished device was done in accordance with the applicable parts of the following voluntary standards, as well as to the company's own internal test protocol. - ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing 1. within a risk management process - 2. EN ISO 14971:2012 Medical devices Application of risk management to medical devices. - FDA General Guidance: 2016 Use of International Standard ISO 10993-1, "Biological 3. evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - 4. ISO 7405:2018 Dentistry Evaluation of biocompatibility of medical devices used in dentistry {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the logo for COLTENE. The logo consists of a series of blue squares on the left side, followed by the word "COLTENE" in bold, black letters. The blue squares are arranged in two rows of three, with each square slightly offset from the others. The testing evaluated flexural strength, flexural modulus, compressive strength, and biocompatibility of the subject device, as well as other related physical properties. The subject device passed all required testing. ### 9. Statement of Substantial Equivalence BRILLIANT EverGlow Flow has the same intended use, indications for use and similar physical attributes as BRILLIANT EverGlow. Any minor differences in the materials used to make the subject device when compared to the predicate device have been successfully evaluated by Coltène/Whaledent through extensive performance and biocompatibility testing on the device, such that the information submitted to the FDA demonstrates that the subject device is as safe and effective as the predicate device and does not raise any new questions of safety and effectiveness. BRILLIANT EverGlow Flow, as designed and manufactured by Coltène/Whaledent, has been determined to be substantially equivalent to BRILLIANT EverGlow.